GSP internal audit self-inspection report

Zhangyi GSP internal audit self-examination report

xx Medical Store was established on x, month x, 200x. It is an individual retail enterprise. Its business scope includes: Chinese medicine pills, Chinese patent medicines , chemical preparations, antibiotics, biochemical products, biological products, the store address is No. xx, xx Town, the business premises is xx square meters, the warehouse area is xx square meters (all are cool warehouses), and the effective volume of the refrigerator is 189l. Since its opening, the sales volume has been nearly xx million yuan, with a gross profit of xx yuan. Nearly xxx types of drugs are sold, and all business activities comply with the laws and regulations stipulated by the state. Since its opening, no fake and inferior drugs have been distributed.

The pharmacy adheres to the business purpose of "recruiting customers sincerely and putting credibility first" and regards GSP as the corporate quality standard. As soon as the pharmacy opens, it will consciously carry out business activities in accordance with the requirements of GSP certification and strive to ensure quality management. Standardization. Especially since this year, through continuous study of drug laws and regulations, GSP and its implementation rules, we have compared the standards of GSP certification item by item, and repeatedly conducted self-examination and rectification. We have achieved obvious results, and the quality management level of pharmacies has become substantial. With the improvement of performance, our store believes that it has basically reached the requirements of GSP certification standards. We will now report on the implementation of GSP certification in our store as follows:

1. Organizational setup and staffing

The implementation of gsp involves many aspects such as drug purchase, storage, sales and after-sales service, and is a full-person, full-process management. In order to ensure the smooth implementation of GSP certification work, the person in charge of the enterprise is specifically responsible for the organization and coordination of GSP certification. At the same time, a corporate quality manager is assigned to be specifically responsible for corporate quality management and organize the implementation of GSP certification work. The company currently has In order to improve the quality of medicines and services, all employees must undergo professional training and obtain employment certificates in accordance with job requirements. In addition, the pharmacy regularly organizes employees to participate in health examinations every year, and establishes health files for each employee to ensure that employees who pass the health examination are in direct contact with drugs. . At present, the staffing of the pharmacy is relatively reasonable and meets the standard requirements of GSP certification.

2. Pay attention to publicity, education and training work

In order to smoothly implement the gsp certification work and improve the professional quality and quality awareness of employees, a training plan has been formulated through a combination of internal and external training, and relevant organizations have been organized successively Personnel participate in on-the-job technical training, marketing technology training and GSP special learning, etc. The GSP special learning content involves relevant laws and regulations on drug operations, drug quality management knowledge, and the quality management system, work procedures, quality responsibilities established by pharmacies, etc. Through learning and training, the professional quality and job skills of the employees have been greatly improved, making employees realize that GSP is the criterion that must be followed in pharmaceutical business activities, ensuring the smooth progress and implementation of GSP certification work.

3. Improve the quality management system

In accordance with the requirements of the "Drug Administration Law", "Pharmaceutical Goods Management Practices" and "GSP Certification Inspection and Evaluation Standards for Drug Retail Enterprises", combined with this Based on the actual situation of the enterprise itself, the person in charge of pharmacy quality organized relevant personnel to formulate the "Pharmacy Quality Management System", "Quality Responsibilities of Personnel at All Levels", and "Drug Quality Control Procedures" to allow each employee to clarify the quality management regulations for each position and make the work There are rules to follow. According to the provisions of the system, the pharmacy quality management team conducts assessments on the implementation of various systems every six months. If problems are found, they will be rectified immediately and corrected in a timely manner.

IV. Increase hardware investment and improve facilities and equipment

In order to effectively implement GSP certification and improve drug operation and storage conditions, our store has purchased refrigerators and air conditioners that are suitable for the scale of operations. , exhaust fans and other temperature and humidity control ventilation equipment; at the same time, shelves are equipped, and rodent-proof equipment is added, so that the warehouse meets the requirements of dust-proof, moisture-proof, anti-pollution, insect-proof, rodent-proof, and mildew-proof. The internal affairs of the warehouse area There is fire safety equipment. At the same time, the pharmacy carries out partition management of the warehouse, with clear color markings, so that the four zones of the warehouse meet the requirements of GSP.

5. Strictly control and strengthen quality management of purchase, storage and sales

In order to ensure effective quality management, pharmacies conduct comprehensive and systematic management of drug purchase, storage and sales. , full tracking, and at the same time, the pharmacy has detailed and true records of the management of the entire operation process to ensure that the drug purchase channels are legal, the drug quality is qualified, and the management tracking is in place, effectively preventing the occurrence of various quality accidents. Since the opening of the pharmacy, no counterfeit or substandard drugs have been distributed, and there have been no adverse reactions or customer complaints related to drug quality.

6. In the process of purchasing, storing, selling and after-sales services of drugs, pharmacies should specifically do the following points

1. The purchase of drugs should be strictly in accordance with the quality management of this pharmacy System implementation, strengthen the review of the supplier's quality assurance system, require suppliers to provide copies of the "Pharmaceutical Business License" and "Business License" with official seals, establish supplier company files, and strengthen the supplier's drug sales Qualification review of personnel and signing of a quality assurance agreement with the supplier; when purchasing imported drugs, the supplier is required to provide the "Imported Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate" or "Pharmaceutical Product Registration Certificate" stamped with the original seal of the supplier's quality management agency. Copy of the Imported Drug Inspection Report: Check the quality from the source.

2. Acceptance of drugs

According to the corresponding laws and regulations, the quality clauses of the contract and the quality standards, the inspectors strictly inspect the appearance, shape, packaging and labeling of the drugs. Those that do not meet the requirements will be firmly rejected.

3. Standardize drug display management

According to gsp requirements, pharmacies standardize drug display management, so that they can be classified according to their use, and at the same time, they should do a good job in distinguishing drugs and non-drugs, internal medicines and External medicines and medicines that are prone to odor are stored separately, prescription medicines and non-prescription medicines are stored in separate cabinets, and disassembled medicines are stored in special counters, and the signs are obvious and clear. Inspect the displayed drugs every month and record them truthfully.

4. Pay attention to the maintenance of drugs

According to the quality management system of the pharmacy, the maintenance staff will reasonably store and display the drugs according to the storage conditions of the drugs, and record them on time every morning and afternoon. Temperature and humidity conditions in warehouses and business premises. When the temperature and humidity do not meet the drug storage requirements, timely control measures will be taken. At the same time, regular inspections of general drugs in stock are carried out quarterly, and key maintenance varieties are inspected monthly. Maintenance files are also established for key maintenance varieties, and maintenance records must be true, complete, and standardized.

5. Do a good job in the sales of drugs

In order to standardize the behavior of the drug business and provide consumers with reliable drugs and quality services, the preparation of prescription drugs shall be reviewed and reviewed by the prescription. Other drugs Sales staff can insist on asking questions and do the "three questions", that is, asking about the condition, asking about gender, and asking about age, that is, explaining the dosage, dosage, and precautions. According to the name of the medicine purchased by the customer, After the specifications, quantities, and prices are verified to be correct, the award medicines will be handed over to ensure the safety and effectiveness of the medicines used by the people. At the same time, pharmacies have clearly stated service conventions in their business stores, announced supervision telephone numbers and set up customer opinion books; and provide consulting services to guide customers in the safe and rational use of medicines.

Part 2 GSP Internal Audit Self-inspection Report

According to the "Drug Administration Law of the People's Republic of China" and the new version of "Pharmaceutical Goods Management Practice" and "Pharmaceutical Quality Management According to the requirements of the "Standard Implementation Rules", our pharmacy attaches great importance to the implementation of GSP and has made careful preparations and comprehensive inspections. The report on the implementation of GSP certification and self-inspection in our pharmacy is now as follows:

1. Enterprise Overview

Our store was established on November 21, 20xx. It is located at No. 12, Building 17, Tianyuan New Village. The person in charge of the company is Wu Aizhi, and the person in charge of quality is Wu Aizhi. Business scope: prescription and over-the-counter drugs, proprietary Chinese medicines, chemical preparations, antibiotic preparations, biochemical drugs, Class B over-the-counter drugs, etc. There are currently 4 employees, including 1 practicing pharmacist, 3 of whom have obtained employment certificates, and a business area of ??106 square meters. There are more than 800 varieties of products in operation.

2. Quality Management and System

Due to the small scale of our store, few staff, and little business, in view of this situation, we only set up a quality management team, consisting of 4 people: Legal person of the pharmacy: Wu Yan, head of quality management: Wu Aizhi (also resident pharmacist), inspector: Shen Yunyun, maintenance worker: Li Fang.

At the beginning of its operation, our pharmacy formulated a set of drug operation quality management documents that suit our actual situation in accordance with GSP requirements. During the operation process, our pharmacy strictly followed the GSP requirements. In the early days of business, some systems were not implemented well and there were irregularities in work. After several rectifications, the system has now been fully implemented and fully complies with the requirements of the new version of "GSP".

3. Personnel and training

In order to continuously improve the professional and technical quality of all employees, we have formulated a learning and training plan and regularly organize all employees to learn drug management laws and regulations and professional and technical knowledge. Conduct assessments every six months and establish training files.

IV. Facilities and Equipment

According to the requirements of the new version of GSP, our company is equipped with computers and drug purchase, sale and inventory management software that meets relevant management requirements, and is equipped with temperature and humidity detection equipment in the business premises. Equipment, now equipped with thermohygrometer and air conditioner. It is also equipped with rodent-proof, insect-proof, and fire-proof equipment. The business premises is clean and bright, with complete business shelves and counters.

5. Drug purchase and acceptance management

In accordance with the requirements of relevant laws and regulations such as the "Drug Administration Law" and "Pharmaceutical Goods Management Practices", the quality and legal qualifications of purchased drugs are checked. review, and request copies of the drug GSP certification, drug business license (wholesale) and business license stamped with the company's official seal. The power of attorney should clearly stipulate the scope and period of authorization; a copy of the ID card of the drug salesperson; purchase For imported drugs, obtain copies of the "Imported Drug Registration Certificate" and "Imported Drug Inspection Report" from the supplier, and stamp them with the original seal of the supplier's quality management agency; imported drugs should have Chinese-labeled instructions. Implement an audit system for first-run enterprises and first-run drugs. The enterprise has established a drug purchase ledger. The ledger records the purchase of medicines truly and completely, ensuring that the invoices, accounts, and items are consistent. It is then entered into the computer according to relevant procedures to complete all basic work.

Acceptance management: Acceptance personnel inspect and record the purchased drugs batch by batch in strict accordance with the relevant regulations based on the original vouchers and tax stamps. It mainly checks whether the accepted drugs meet the corresponding appearance quality standards. (1) Whether the outer packaging is firm and dry; whether the seals and seals are damaged; whether the outer packaging is marked with the common name, specifications, manufacturer, approval number, registered trademark, batch number, and validity period. Whether specific storage and transportation markings comply with pharmaceutical packaging requirements. (2) Whether each piece of inner packaging has a product certificate, whether the container is reasonable, whether it is damaged, whether the sealing is tight and qualified, the packaging writing should be clear, and the product name, specification, batch number, etc. must not be missing; the bottle label must be firmly affixed. (3) The generic name, ingredients, specifications, manufacturer name, approval number, production batch number, production date, validity period, etc. of the drug are clearly printed on the drug label and instructions. The label or instructions should also include indications or main functions, usage and dosage, contraindications, adverse reactions, precautions, and storage conditions. (4) The labels on the packages of the imported drugs that are accepted shall indicate the name, main ingredients and registration number in Chinese, with instructions in Chinese, and be accompanied by the "Imported Drug Registration Certificate", "Imported Medicinal Material Approval Document" and "Imported Drug Inspection Report". And stamped with a copy of the red seal of the supplier's quality management organization. Collect adverse drug reactions in a timely manner and report any adverse reactions to the drug regulatory department immediately.

6. Drug Storage, Maintenance and Display (Retail) Management

When our company was first established, we strictly followed GSP requirements and created a storage and display environment with high standards. According to the market The business area has been renovated according to bureau standards, making the business place spacious and bright. Shopping is convenient, the signs are eye-catching, and medicines are classified according to business conditions and GSP requirements. According to the performance and nature of the drugs, the warehouse is divided into areas to be inspected (yellow), combined drugs (green), unqualified drugs (red) and returns (yellow). Drugs and non-drugs, external drugs and internal medicines are stored in separate areas to facilitate operation and prevent errors and contamination incidents. Shelves, greenhouse thermometers, light-shielding facilities (curtains), and rodent-proof facilities (door seam seals) have been added to meet the requirements of the "seven preventions" (dust-proof, insect-proof, bird-proof, rodent-proof, moisture-proof, mildew-proof, and pollution-proof) . Lighting equipment that meets lighting requirements is installed. All business areas are equipped with air conditioners to ensure appropriate air humidity and temperature.

At work, management is carried out in accordance with the store's "drug storage, maintenance and display management system", such as the "four separation principles" of displaying drugs and non-drugs separately, non-prescription drugs and prescription drugs, internal medicines and external medicines, etc. Special counters for special preparations containing ephedra are displayed and marked with warning slogans. The counters in the dismantling area are equipped with relevant dismantling tools. In addition, the temperature and humidity of the business area and warehouse are measured every morning and afternoon, and timely measures are taken to control if the requirements are not met; maintenance and inspection of the inventory and display of medicines are carried out regularly every month, and records are recorded as required.

7. Sales and after-sales service

In order to provide consumers with reliable medicines and high-quality services, companies conduct business training and assessments for salespeople engaged in pharmaceutical retail work. When selling medicines, according to the customer's requirements, the medicines purchased will be handed over to the customers after verification, and a sales voucher will be issued. At the same time, the instructions for taking the medicines and contraindications will be explained to the customers in detail; the service agreement will be clearly stated in the business premises, the supervision telephone number will be announced, and the customer will be set up. Opinion Book. Customer evaluations and complaints will be resolved in a timely manner, and drug quality issues reported by customers will be taken seriously, recorded in detail, and handled in a timely manner.

8. Computer software system

The computer system was developed by a well-known domestic company: Shenzhen Wanguosixun Software Co., Ltd. Relevant modules comply with the application requirements of the new version of GSP. It can automatically remind the inventory amount every day, and can provide monthly sales reminders for products with a near-expiry date. Expired companies and expired drugs can automatically limit related procurement, acceptance, sales and other activities. Cannabis-containing preparations can be Automatically carry out limited sales and register name and ID card sales, etc.

9. Self-examination situation

Our pharmacy has established a self-examination team, led by manager Wu Yan and led by the quality manager, to conduct self-examination and rectification of the store's implementation of GSP management. :

The first is to scientifically summarize and organize relevant files and records; the second is to fill in the sales labels on the shelves in a standardized manner; the third is to re-clean the store; the fourth is to further inspect the classified management. and standardize. Through self-examination and self-correction activities, GSP management level has been further improved.

Part 3 GSP Internal Audit Self-inspection Report

1. Quality Management Organization and System

As the company’s business scale and scope gradually increase, our company continues to Adjust and improve the company's quality system, enrich the quality management organization and personnel, clarify the responsibilities of each department and personnel, formulate corporate quality management policies and goals, prepare quality management program documents and operating procedures, and implement regular inspections and assessments to ensure The company's quality management personnel exercise their powers and allocate quality management institutions and personnel in a more scientific and reasonable manner; according to the relevant regulations and requirements of GSP, they gradually revise and review various quality management systems, quality work procedures, institutions and job responsibilities, so as to ensure the company's quality management work. We must have evidence and rules to follow, and improve the company's quality management system documents so that various quality management systems and work procedures can be effectively implemented.

The company has established an independent quality management department and a full-time acceptance and maintenance team. The Quality Control Department has a quality management group and a quality acceptance group, which can implement relevant drug laws and regulations and company quality management documents. The Quality Control Department performs quality management functions in all aspects of enterprise operation and has the power to adjudicate drug quality within the enterprise.

The company has formulated an internal audit system for the quality management system and conducts regular internal audits of GSP operations to ensure the normal operation of the quality system.

2. Personnel training

In order to improve the comprehensive quality of all employees, our company not only actively participated in various trainings organized by the province and city, but also held a series of internal trainings. This includes legal and regulatory training, company systems, work procedures, responsibility training, skills training for each position, drug classification knowledge training and employee moral education, etc. All trainings are assessed, and training files and assessment files are established to achieve more obvious training effects.

The company’s leadership also attaches great importance to the study of relevant national drug laws and regulations and drug business management knowledge, and regularly organizes study and training. The person in charge of the company and the person in charge of quality are all university graduates. The deputy general manager in charge of quality, manager of the quality control department and other quality management personnel are all practicing pharmacists with a bachelor's degree or above and have rich practical experience and management capabilities. The personnel engaged in quality acceptance, maintenance and sales all have a college degree or above.

In accordance with GSP’s requirements for all types of personnel, the company conducts health examinations for employees who are in direct contact with drugs. After passing the examination, they will be employed with certificates and establish health files. They will strictly follow relevant rules and regulations at work.

3. Facilities and Equipment

Our company’s business and office space covers an area of ??*** square meters, which can meet daily business and office requirements. The office environment is bright, clean, and reasonably laid out. Equipped with necessary modern office equipment and implement computerized management of purchase, sale and inventory.

The warehouse area is *** square meters, including *** square meters of cold storage, *** square meters of cool warehouse, *** square meters of Chinese medicinal materials and Chinese herbal pieces warehouse, and *** square meters of medical equipment warehouse. m, which can adapt to the requirements of the medicines stored by our company. The warehouse must be reasonably laid out, with flat floors, tight doors and windows, no sources of pollution, dust-proof, moisture-proof, mildew-proof, pollution-proof, insect-proof, rodent-proof, bird-proof equipment and facilities, and fire safety facilities that meet the requirements. The area to be inspected, the qualified product area, the unqualified product area, the return area, and the shipping area are subject to color mark management. The qualified product area is effectively isolated from the unqualified product area and the return area. The storage operation area, auxiliary operation area, and office living area are effectively separate. Each warehouse is equipped with complete temperature and humidity monitoring and control equipment, which can adapt to the requirements for the storage of drugs operated by the company in separate warehouses and zones according to physical and chemical properties and storage conditions.

The inspection and nursing room covers an area of ??*** square meters, equipped with a thousandth balance, clarity detector, moisture meter, ultraviolet fluorescent lamp, standard colorimetric solution, microscope, specimen room, retail area and drying For special equipment such as oxygen reduction, fumigation, and maintenance, equipment files and usage and maintenance files are established for various inspection and maintenance instruments and equipment.

IV. Purchase Management

The purchase management of medicines is the first level of quality control in pharmaceutical operations. It is also a key link to ensure the legality of business operations and the quality of pharmaceutical operations. . Our company adheres to the principle of taking quality as the premise and purchasing goods on demand, and implements unified management of drugs. The purchasing department organizes the procurement, and each business department sells them separately. The Purchasing Department formulates a purchasing plan every month. The formulation of the purchasing plan requires the participation of relevant personnel from the Quality Control Department and is reported to the leader in charge for approval and then filed.

Strictly control the quality of drug procurement, conscientiously implement the approval system and procedures for first-run enterprises and first-run varieties, the drug purchase system and its procedures, pay attention to the investigation of the quality assurance system of supplier units, and ensure that all suppliers Ensure the legality of the purchasing unit and the purchased drugs, sign a 100% drug quality assurance agreement with the supplier, make the drug purchase voucher complete and authentic, and establish a qualified supplier file.

5. Acceptance management

Our company’s quality control department is responsible for the quality acceptance of purchased drugs and sales of returned drugs. The quality control department has set up a special acceptance team, and the inspectors strictly follow the quality inspection The relevant systems and procedures for acceptance are carried out in the curing room.

In accordance with legal standards and procurement contracts, acceptance personnel conduct drug quality inspections on batches of purchased drugs in accordance with prescribed proportions. They also conduct acceptance inspections on the appearance and properties of first-market varieties, injections, and first-time purchased drugs of various dosage forms. , resolutely reject substandard drugs and counterfeit and substandard drugs, and ensure that the acceptance rate of drugs entering the warehouse is 100%. All imported drugs have imported drug registration certificates and imported drug inspection reports stamped with the original seal of the supplier's quality management agency. External medicines and OTC medicines are inspected and accepted according to the prescribed labels.

Drug acceptance records are the core basis for enterprise quality acceptance. All qualified drugs must fill in the quality acceptance record in detail. The content of the record should be true and complete. The acceptance conclusion should be prepared and signed by relevant personnel. The acceptance record must be Save according to regulations.

6. Storage and Maintenance

In terms of storage of drugs, our company strictly follows the storage requirements of drugs and stores them in separate warehouses. First, the drugs are stored in separate warehouses according to the required storage conditions. In normal temperature warehouses, cool warehouses and refrigerated warehouses, secondly, according to their natural properties, internal and external medicines should be stored separately, drugs that are prone to odor transfer, non-drugs should be stored in special warehouses, and drug reports for near-expiration dates should be filled out at the prescribed time every month.

Take care of your medicines carefully. According to the drug classification regulations, the stored drugs are identified as key maintenance varieties, a key maintenance plan is formulated, cyclic maintenance is carried out every month, drug maintenance records and maintenance files are established, and storage and in-warehouse maintenance are carried out strictly according to the physical and chemical properties and storage conditions of the drugs to ensure that they are stored in the warehouse. The quality of the drugs in the warehouse is intact; temperature and humidity records are kept every day, the temperature and humidity of the warehouse are adjusted in a timely manner, and problems are reported in a timely manner.

For drugs returned by the company’s sales, they will be handled in accordance with relevant operating procedures. The custodian will receive the goods with the return voucher issued by the sales department and store them in the return area. After the acceptance is passed by the inspector, they will be placed in the qualified product warehouse. In the unqualified area where unqualified drugs are stored, the confirmation, reporting, damage reporting and destruction of unqualified drugs shall be carried out in accordance with prescribed procedures, and complete records and files shall be established.

7. Outgoing warehouse and transportation

When outgoing drugs, we strictly implement the principle of shipment according to batch number, strictly implement the outgoing review system, and review the drugs item by item. During the review, it is found that there are If there is a quality problem, the shipment will be stopped immediately and reported to the quality management department to ensure that unqualified drugs are not shipped out of the warehouse. According to the physical and chemical properties of the drug and transportation conditions, necessary refrigeration and insulation equipment and transportation safety facilities such as heat preservation and cold protection will be equipped to ensure that during transportation Drug quality.

8. Sales and after-sales service

In order to strengthen drug sales and services, custodians and reviewers carefully review the quantity of drugs and check the quality of drugs. The sales department conducts sales activities in strict accordance with relevant laws, regulations and the company's quality management system to ensure that drugs are sold to legally qualified units. Adhere to operating in accordance with the law, do not have business relationships with units that are not qualified to operate and use drugs, ensure that all drug sales have legal receipts, and establish complete sales records.

Ensure service quality, implement quality inquiry system, and provide good after-sales service. The company advocates enthusiastic service and establishes customer complaint record files to track and implement. The company regularly conducts drug quality inquiries on customers and suppliers, promptly delivers feedback on drug quality information, summarizes it regularly, and establishes drug quality inquiry records and quality information transmission feedback records. Track and monitor the occurrence of adverse drug reactions, report them in a timely manner, and recover drugs in a timely manner to ensure the safety and effectiveness of drugs.